Silver Diamine Fluoride Pilot Study (SDF) (SDF)
![]() |
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
ClinicalTrials.gov Identifier: NCT02591147 |
Recruitment Status :
Active, not recruiting
First Posted : October 29, 2015
Last Update Posted : December 28, 2021
|
- Study Details
- Tabular View
- No Results Posted
- Disclaimer
- How to Read a Study Record
Condition or disease | Intervention/treatment | Phase |
---|---|---|
Dental Caries | Device: Silver Diamine Fluoride 38% Device: Group 2 (Placebo) | Not Applicable |
This pilot study will compare 1) Silver diamine fluoride (SDF) and fluoride varnish to 2) Placebo and fluoride varnish (conventional prevention) in the management of early approximal carious lesions. Early approximal carious lesions refers to decay between teeth, diagnosed with radiographs, not extending more than 1/3 of the way into dentin. Management of early approximal carious lesions refers to halting lesion progression, or encouraging lesion reversal after an early carious lesion is detected.
SDF provides a novel, low-cost intervention option for managing early carious lesions that could potentially bridge the 'gap' between non-operative and operative options; thus, postponing the first placement of a restoration. SDF has been used in arresting carious lesions for more than 100 years. However, SDF has never been tested in the arrest of approximal caries lesions in permanent teeth.
SDF acts to both prevent and arrest tooth decay in multiple ways: 1) it acts on the body of carious lesions by precipitating silver ion into the lesion, thus blocking diffusion pathways for cariogenic acids; 2) it interacts with dental enamel leading to the formation of fluoroapatite crystals making the tooth surface more acid resistant; and 3) the precipitated silver from SDF acts as a bactericidal agent disturbing the formation of cariogenic biofilm.
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 55 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Double (Participant, Investigator) |
Primary Purpose: | Health Services Research |
Official Title: | Effectiveness of Silver Diamine Fluoride in Arresting Early Approximal Carious Lesion Progression: A Pilot Study |
Actual Study Start Date : | January 7, 2016 |
Actual Primary Completion Date : | August 1, 2021 |
Estimated Study Completion Date : | June 30, 2022 |
Arm | Intervention/treatment |
---|---|
Active Comparator: Silver Diamine Fluoride 38%
Group 1 (SDF 38%) will receive the application of silver diammine fluoride (38% SDF solution) in addition to 5% sodium fluoride varnish to each approximal carious lesion (scores RA1,RA2,RA3) in a posterior tooth (premolar or molar) that is in contact with an adjacent tooth, using super floss, for a duration of 3 minutes under rubber dam isolation.
|
Device: Silver Diamine Fluoride 38%
Group 1 (SDF group) subjects will receive the application of silver diamine fluoride (38% SDF solution) in addition to 5% Fluoride varnish to each approximal incipiency, using super floss, for a duration of 3 minutes under rubber dam isolation.
Other Name: 38% SDF |
Placebo Comparator: Placebo (Sterile water)
Group 2 Placebo (control) will receive the application of sterile water (placebo) in addition to 5% sodium fluoride varnish to each approximal carious lesion (scores RA1,RA2,RA3) in a posterior tooth (premolar or molar) that is in contact with an adjacent tooth, using super floss, for a duration of 3 minutes under rubber dam isolation.
|
Device: Group 2 (Placebo)
Group 2 (Placebo) subjects will receive application of sterile water (placebo) in addition to 5% Fluoride varnish to each approximal incipiency, using super floss, for a duration of 3 minutes under rubber dam isolation.
Other Name: Sterile Water |
- Caries Progression [ Time Frame: 12 months ]comparison of radiographs to determine if there is caries progression in the subjects approximal lesions based on the radiographic examination.
- Incidence of caries in all other teeth in the study subject [ Time Frame: 12 months ]Count for new carious lesions developing over the course of the study period to assess the effect of SDF on preventing the development of early carious lesions

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
Ages Eligible for Study: | 21 Years to 64 Years (Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
- Presence of at least one approximal caries lesion (scores RA1, RA2, RA3 according to the ICCMS radiographic scoring system) in one of the posterior teeth (premolars and molars) presented with full contact with the adjacent tooth.
- All the surfaces eligible for this study will be included.
Exclusion Criteria:
- The approximal lesion detected in the radiograph has advanced dentine lesion (RB4, RC5, or RC6)
- or is adjacent to a lesion that is either filled or will receive a filling at the time of enrollment.

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02591147
United States, Iowa | |
University of Iowa | |
Iowa City, Iowa, United States, 52242 |
Principal Investigator: | Michael Kanellis, DDS, MS | University of Iowa | |
Principal Investigator: | Justine Kolker, DDS, MS | University of Iowa |
Responsible Party: | Justine Kolker, Principal Investigator, University of Iowa |
ClinicalTrials.gov Identifier: | NCT02591147 |
Other Study ID Numbers: |
201509831 |
First Posted: | October 29, 2015 Key Record Dates |
Last Update Posted: | December 28, 2021 |
Last Verified: | December 2021 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | No |
Studies a U.S. FDA-regulated Device Product: | Yes |
Dental Caries Tooth Demineralization Tooth Diseases Stomatognathic Diseases |
Fluorides Cariostatic Agents Protective Agents Physiological Effects of Drugs |